MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

Event Type  malfunction  

Event Description

It was reported that a patient presented during pacemaker implant procedure with a pacemaker with a header anomaly.The left ventricular lead pin would not go all the way into the port on the header.The end of the pin would not advance past the set screw.A replacement pacemaker was used and the lead was able to be plugged in and the pin was visualized past the set screw.Patient was stable.

Manufacturer Narrative

The reported complaint of not fully being able to insert the lv lead into the lv-connector was confirmed in the laboratory.Analysis found that once the setscrew was backed out from blocking the connector port, the leads were able to be fully inserted with normal insertion force.The setwcrew was tightened down on the lead and the lead was found to be held firmly in place.All connector dimensions were with specifications.The cause of the event was traced to a user related anomaly due to failing to properly follow the user manual instructions.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8780761
• MDR Text Key: 150709080
• Report Number: 2017865-2019-10767
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000081189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1